Comparison of Ultrasound-Guided Fascia Iliaca Compartment Block Versus Intravenous Tramadol for Positioning of Femur Fracture Patients Before Spinal Anaesthesia

NCT07735884 | Completed

• 1 other identifier: Mayo8
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical study compared two methods of pain relief used before spinal anaesthesia in patients undergoing surgery for a femur fracture. Positioning a patient with a fractured femur into the side-lying position required for spinal anaesthesia can cause severe pain because movement may disturb the fractured bone. A total of 64 patients aged 18 to 60 years were included and were assigned to one of two treatment groups. One group received intravenous tramadol, while the other group received an ultrasound-guided fascia iliaca compartment block, in which local anaesthetic was injected near the nerves supplying the hip and upper thigh. Pain was measured using a visual analogue scale when the patient arrived on the operating table and again during positioning in the lateral decubitus position before spinal anaesthesia. The study was conducted to determine which treatment provided better pain relief and made positioning for spinal anaesthesia more comfortable. It was hypothesized that the ultrasound-guided fascia iliaca compartment block would reduce pain during positioning more effectively than intravenous tramadol.

Conditions

Acute Pain; Femoral Fractures

Keywords

Ultrasound-Guided Fascia Iliaca Compartment Block; Intravenous Tramadol; Femoral Fracture; Spinal Anaesthesia; Lateral Decubitus Position

Outcome Measures

Primary Outcomes (1)

• Pain Intensity During Positioning for Spinal Anaesthesia

  Pain intensity was assessed using a 0-10 visual analogue scale during placement of the participant in the lateral decubitus position before spinal anaesthesia. A score of 0 represented no pain, while a score of 10 represented the worst possible pain. Lower scores indicated better analgesic efficacy.

  10 minutes after intravenous tramadol or 15 minutes after ultrasound-guided fascia iliaca compartment block, immediately before spinal anaesthesia.

Secondary Outcomes (1)

• Change in Visual Analogue Scale Pain Score From Baseline to Positioning

  10 minutes after intravenous tramadol or 15 minutes after fascia iliaca compartment block.

Study Arms (2)

Ultrasound-Guided Fascia Iliaca Compartment Block Group

EXPERIMENTAL

Participants received an ultrasound-guided fascia iliaca compartment block through the infrainguinal approach using 30 mL of 1% lidocaine with adrenaline. After 15 minutes, participants were positioned in the lateral decubitus position for spinal anaesthesia, and pain intensity was assessed using the visual analogue scale.

Procedure: Ultrasound-Guided Fascia Iliaca Compartment Block

Intravenous Tramadol Group

ACTIVE COMPARATOR

Participants received intravenous tramadol at a dose of 1 mg/kg. After 10 minutes, participants were positioned in the lateral decubitus position for spinal anaesthesia, and pain intensity was assessed using the visual analogue scale.

Drug: Tramadol

Interventions

Ultrasound-Guided Fascia Iliaca Compartment Block PROCEDURE

An ultrasound-guided infrainguinal fascia iliaca compartment block was administered with 30 mL of 1% lidocaine containing adrenaline.

Ultrasound-Guided Fascia Iliaca Compartment Block Group

Tramadol DRUG

Tramadol was administered intravenously at a dose of 1 mg/kg before positioning for spinal anaesthesia.

Intravenous Tramadol Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years
• Male or female patients
• American Society of Anesthesiologists physical status I or II
• Patients scheduled for femur fracture surgery under spinal anaesthesia

You may not qualify if:

• Multiple fractures
• Peripheral neuropathy
• Inability to communicate or provide reliable pain assessment
• History of allergy to local anaesthetic agents
• Contraindication to spinal anaesthesia, including:
• Patient refusal
• Local infection at the injection site
• Coagulopathy

Sponsors & Collaborators

• Mayo Hospital Lahore: lead

Study Sites (1)

Mayo Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Femoral Fractures; Acute Pain

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Adeel Ahmed

  Mayo Hospital Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: July 30, 2026
• Study Start: August 10, 2024
• Primary Completion: February 10, 2025
• Study Completion: February 10, 2025
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

PA (1)